Surgical methods for suspending a prolapsed vagina (also known as fallen vagina) to the sacrospinous ligament and/or the iliococcygeus muscle and fascia to surgically correct vaginal vault prolapse are well documented. Such suspensions have been well-described and studied in the literature using both absorbable and non-absorbable sutures.
For example, a transvaginal surgical approach for the treatment of utero-vaginal and vaginal vault prolapse has been used for decades. This vaginal approach still uses sutures to suspend the vagina to either the sacrospinous ligament, cardinal ligament, or to the iliococcygeus muscle and fascia. More recently, transvaginal techniques have used trochars to insert mesh to support the uterus and/or vagina but these techniques have been found to have undesirable postoperative complications, including mesh erosion, pelvic pain, and pain with sexual relations. There are also known transabdominal and laproscopic procedures that are performed to suspend the prolapsed organs to the sacral promontory (i.e. the upper part of the tail bone) using a piece of mesh as a bridge between the two fixation sites. These procedures require general anesthesia and single or multiple abdominal incisions and have a risk of vaginal mesh erosion, as well as bowel mesh entrapment or erosion with resultant bowel perforation and obstruction.
In the transvaginal approach, using various suture delivery systems requires opening the posterior or anterior vaginal wall, and extensive dissection into perirectal space to reach the appropriate desired fixation site. The surgery is deep within the pelvis, is difficult to perform, and requires surgical experience and training. When using sutures that absorb, the fixation site on the vaginal side can go into and through the vaginal wall or, if using a permanent suture, must be buried beneath the vaginal wall so as not to erode through the vaginal wall. Delayed absorbable sutures can also be placed without a vaginal incision by placing them through the appropriate area in the vaginal wall into the iliococcygeus muscle and fascia and back out into the vagina and then tying them. Unfortunately, because of the curve of the needle, appropriate and especially adequate placement into the muscle and its fascia is difficult.
In the transvaginal approach, the suspension to the sacrospinous ligament is considered the gold standard. The problem with this suspension is that it is usually performed only on the patient's right side, as the sigmoid colon on the patient's left may be injured during dissection. This unilateral suspension causes the vagina on that side to be pulled to the right side which can lead to vaginal narrowing, shortening and stenosis if too much vaginal wall is excised. This can lead to pelvic pain and pain with sexual relations. If the vagina is very wide at the top after a unilateral suspension, it can expose the opposite unsuspended vaginal wall to excessive downward force that may lead to prolapse. Moreover, whether using one or two permanent or absorbable sutures in the suspension, these stitches may tear leading to recurrent prolapse.
Accordingly, there exists a need for a device and method that can be used to readily and easily support one or both sides of the vaginal wall to the iliococcygeus muscle and fascia and/or the sacrospinous ligament without necessitating opening the vaginal wall and dissecting into the perirectal space.